Glaukos Announces Positive Topline Outcomes in Phase 3 Confirmatory Trial for Epioxa™, Achieving Primary Efficacy Endpoint and Demonstrating Favorable Tolerability and Safety
Phase 3 Confirmatory Trial Met Pre-Specified Primary Efficacy Endpoint and Demonstrated Excellent Tolerability and a Favorable Safety Profile Through 12 Months, Supporting Anticipated New Drug Application (NDA) Submission by End of 2024
Data Suggest Epioxa Has the Potential to Provide the
“We are excited to announce these positive Phase 3 confirmatory results that met the study’s primary efficacy endpoint and once again demonstrated the potential of Epioxa to halt or reduce the advancement of keratoconus, a progressive, sight-threatening corneal disease. These results further underscore our view that Epioxa may provide the ophthalmic community and keratoconus patients with the first FDA-approved, non-invasive, bio-activated drug treatment alternative designed to reduce procedure time, improve patient comfort and shorten recovery time,” said
Topline summary results and observations from the Phase 3 confirmatory pivotal trial are as follows:
- The Epioxa Phase 3 clinical trial successfully achieved its primary efficacy outcome by demonstrating a Kmax treatment effect of –1.0 diopter (D) (p <0.0001), determined as prospectively defined least square mean Kmax change from baseline in the Epioxa treated arm versus the sham/placebo-controlled arm at the Month 12 study endpoint.
- The treatment was generally well-tolerated, with 91.5% of enrolled treatment patients completing the 12-month trial, compared to 90.9% of enrolled control patients. No patients randomized to Epioxa treatment discontinued early due to an adverse event and there were no ocular serious adverse events reported. The majority of adverse events reported were mild and transient in nature. There was no evidence of treatment-related systemic effects reported in the study and there was no change in corneal endothelial cell counts over the 12-month evaluation period.
The multi-center, randomized, placebo and sham controlled Phase 3 confirmatory pivotal trial randomized 312 eyes and was designed to evaluate the safety and efficacy of Glaukos’ Epioxa therapy in impeding the progression of, and/or reducing Kmax, in eyes with progressive keratoconus. The study eyes were randomized in a 2:1 ratio to receive Epioxa therapy or placebo and sham procedure control treatment. The study’s primary efficacy endpoint was the mean change in Kmax from baseline to Month 12. Based on a special protocol assessment (SPA) agreement with the
Results from this second Phase 3 confirmatory pivotal trial together with the already-completed first Phase 3 pivotal trial are expected to support Glaukos’ anticipated NDA submission for Epioxa by the end of 2024. As a reminder, the
Glaukos’ corneal cross-linking iLink therapies use proprietary, bio-activated, single-use drug formulations to strengthen corneal tissue and halt progression of keratoconus. Typically diagnosed in a patient’s teenage years, keratoconus is a debilitating eye condition characterized by progressive thinning and weakening of the cornea. If left untreated, keratoconus can lead to loss of vision and even blindness and is one of the leading causes of corneal transplant (penetrating keratoplasty) in
Epioxa, which is designed to preserve the corneal epithelium, reduce procedure times, improve patient comfort and shorten recovery time, utilizes a proprietary, novel drug formulation designed to penetrate the epithelial layer of the cornea, a stronger UV-A irradiation protocol and the ability to deliver increased levels of supplemental oxygen to enhance cross-linking. If approved, the company anticipates Epioxa would be the first FDA-approved, non-invasive corneal cross-linking therapy that does not require removal of the corneal epithelium, the outermost layer of the front of the eye.
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Forward-Looking Statements
All statements other than statements of historical facts included in this press release that address activities, events or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for forward-looking statements contained herein, we caution you that they are based on current expectations about future events affecting us and are subject to risks, uncertainties and factors relating to our operations and business environment, all of which are difficult to predict and many of which are beyond our control, that may cause our actual results to differ materially from those expressed or implied by forward-looking statements in this press release. These potential risks and uncertainties include, without limitation, the extent to which we may obtain regulatory approval for Epioxa or other investigational products, our ability to successfully commercialize such products, and the continued efficacy and safety profile of our products when commercially marketed as compared to their pre-approval clinical trial results. Historical, current and forward-looking sustainability-related statements may be based on standards for measuring progress that are still developing, internal controls and process that continue to evolve, and assumptions that are subject to change in the future. The information included in, and any issues identified as material for purposes of this document may not be considered material for
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